Background
Levofloxacin hemihydrate (LEV) and ambroxol HCl (AMB) are available for the treatment of upper and lower respiratory tract infections. A survey of the literature reveals that two reversed phase HPLC
Conclusion
The suggested method was successfully applied for the simultaneous analysis of the studied drugs in their co-formulated tablets and human plasma. The mean percentage recoveries in combined tablets were 100.20 ± 1.64 and 100.72 ± 1.11 for LEV and AMB, respectively and 100.10 ± 1.14 for LEV in spiked human plasma. Statistical comparison of the results with those of the comparison method revealed good agreement and proved that there were no significant difference in the accuracy and precision between the two methods respectively.
Results
The method showed good linearity over the ranges of 1-44 μg/mL and 1-20 μg/mL with limits of detection 0.26 and 0.07 μg/mL and limits of quantification 0.80 and 0.20 μg/mL for LEV and AMB, respectively. The method was further extended to the determination of LEV in spiked human plasma with mean percentage recoveries of 100.10% ± 1.14 as well as determination of LEV in real human plasma without prior extraction. Statistical evaluation of the data was performed according to ICH Guidelines.